Study in Chronic Kidney Disease (CKD) Not on Dialysis
Phase 3
Completed
- Conditions
- Hyperphosphatemia
- Interventions
- Drug: PlaceboDrug: Fosrenol (Lanthanum Carbonate, BAY77-1931)
- Registration Number
- NCT01110629
- Lead Sponsor
- Bayer
- Brief Summary
The objective of this study is to investigate the efficacy and safety of lanthanum carbonate 750 to 2,250 mg in Japanese Chronic Kidney Disease Stage 3, 4 and 5 subjects not on dialysis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 143
Inclusion Criteria
- Male and female patients aged 20 years or above at the time of informed consent
- Chronic Kidney Disease patients with Epidermal growth factor receptor (eGFR) under 60 ml/min/1.73m2 (stage 3, 4 and 5) who have not been on dialysis
- Patients who had been in the care of a physician for Chronic Kidney Disease for >2 months and was not expected to begin dialysis for at least 4 months
- Patients with serum phosphate levels 5.6 mg/dL to 11.0 mg/dL at Week -4 (Visit 1) or Week -2 (Visit 2)
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Exclusion Criteria
- Patients with hypocalcemia or hypercalcemia (corrected serum calcium level of < 7.0 mg/dL or >/- 11.0 mg/dL) at Week -2 (Visit 2).
- Significant renal impairments
- Had acute renal failure within 3 months of Run-in period
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 2 Placebo - Arm 1 Fosrenol (Lanthanum Carbonate, BAY77-1931) -
- Primary Outcome Measures
Name Time Method The change from baseline in serum phosphate concentrations Week 8
- Secondary Outcome Measures
Name Time Method Serum intact PTH level Week 0, Week 2, Week 4, Week 6, Week 8 Phosphate excretion in urine Week 0, Week 4, Week 8 Achievement of target serum phosphate level (2.7 to 4.6 mg/dL) Week 0, Week 2, Week 4, Week 6, Week 8 Change in serum Calcium x Phosphor product Week 0, Week 2, Week 4, Week 6, Week 8